Rhythm Shares Shoot Higher Following Pre-marketing Authorization From French Regulatory For Multisystem Disorder Candidate

The French National Agency for Medicines and Health Products Safety (ANSM) and Haute Autorité de santé (HAS) have granted pre-marketing authorization AP1 (early access authorization), for Rhythm Pharmaceuticals’ RYTM lead candidate IMCIVREE (setmelanotide) in patients with genetically-confirmed Bardet-Biedl syndrome (BBS) for the treatment of obesity and the control of hunger.

The pre-marketing authorization is supported by the review of efficacy and safety data readout from clinical studies by the ANSM and HAS.

Yann Mazabraud, Executive Vice President and Head of International, commented : “We are delighted to announce that the French regulatory authorities granted AP1 status to setmelanotide, making it available for patients with BBS living with hyperphagia and severe obesity. We look forward to collaborating with the broad and established network of French BBS experts to deliver setmelanotide to patients living with BBS in France, as we work to transform the care of patients with BBS globally."

The AP1 allows for early access to innovative therapies in France prior to regulatory approval when a positive benefit/risk ratio is recognized and when no other therapeutic alternatives are available.

Bardet-Biedl syndrome (BBS) is a rare genetic disease that thrives insatiable hunger, known as hyperphagia, and severe obesity, and also associated with cognitive impairment, polydactyly, renal dysfunction, hypogonadism, and visual impairment.

Price Action : Rhythm shares are trading around 23 percent higher at $13.13 on Wednesday at the time of publication.